A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01263704|
Recruitment Status : Completed
First Posted : December 21, 2010
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lymphocytic Leukemia, Chronic||Drug: Cyclophosphamide Drug: Fludarabine Drug: Rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Multicenter, Single Arm Study to Determine the Efficacy and Safety of Low Dose Fludarabine and Cyclophosphamide Combined With Standard Dose Rituximab as Primary Therapy in Elderly Untreated Patients (>/=65 Years Old) With Chronic Lymphocytic Leukemia|
|Actual Study Start Date :||July 17, 2011|
|Actual Primary Completion Date :||April 3, 2017|
|Actual Study Completion Date :||April 3, 2017|
Experimental: Rituximab plus Fludarabine and Cyclophosphamide
Elderly participants with chronic lymphocytic leukemia (CLL) will receive combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment is followed by a follow up period of 36 months.
150 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1-3 of each 28-day cycle for 6 cyclesDrug: Fludarabine
12.5 mg/m^2 IV on Days 1-3 of every 28-day cycle for 6 cyclesDrug: Rituximab
375 mg/m^2 IV Day 0 of Cycle 1, 500 mg/m^2 IV Day 1 of Cycles 2-6. Each cycle was 28 days.
Other Name: MabThera/Rituxan
- Overall Response Rate [ Time Frame: Up to 42 months ]Overall response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to National Cancer Institute - Working Group [NCI-WG] guidelines. CR: no clonal B lymphocytes in peripheral blood, no significant lymphadenopathy, liver and spleen normal size, no disease symptoms, blood counts: absolute neutrophil count (ANC) >1,500/microliter (mcL), platelets > 100,000/mcL, hemoglobin > 11.0 grams/deciliter (g/dL), normocellular bone marrow. PR: >/= 50% decrease in clonal B lymphocyte count, >/= 50% reduction in lymphadenopathy, >/= 50% reduction of liver or spleen enlargement and ANC >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 11.0 g/dL OR >/= 50% increase in ANC, platelets or hemoglobin.
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 53 months ]An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as adverse events. An SAE is any experience that suggests a significant hazard, contraindication, side effect, or precaution, and fulfills any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
- Percentage of Participants With Neutropenic Fever, Infection, >/= Grade 3 Drug-Related Neutropenia, >/= Grade 3 Drug-Related Thrombocytopenia, Hospitalizations [ Time Frame: Up to 53 months ]
- Hospitalization Days [ Time Frame: Up to 53 months ]
- Progression-free Survival (PFS) [ Time Frame: Up to 53 months ]PFS was defined as the interval from the first study drug treatment day to the first sign of disease progression according to NCI-WG guidelines. Progressive disease (PD): Any new lesion, any disease symptoms, >/=50% increase in lymphadenopathy, splenomegaly, hepatomegaly, >/= 50% increase in the number of circulating clonal B lymphocytes, decrease of hemoglobin levels by > 2.0 g/dL, >/= 50% decrease of platelet counts, increase of lymphocytes in bone marrow to more than 30% from normal.
- Quality of Life (QoL): Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Questionnaire [ Time Frame: [Visit 1 (Screening, Week 0), at Visits 11 (Week 45) and 14 (Week 80) and at the end of the study (Month 42)] ]The FACIT-F questionnaire consists of 13 questions with a total score range of 0 to 52 with 0 indicating a better outcome and 52 indicating a worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263704
|Haemek Medical Center; Hematology Department|
|Afula, Israel, 18101|
|Soroka Medical Center; Hematology Deptartment|
|Beer Sheva, Israel, 8410101|
|Rambam Medical Center; Heamatology & Bone Marrow Transplantation|
|Haifa, Israel, 3109601|
|Bnei-Zion Medical Center; Hematology Dept|
|Haifa, Israel, 3339419|
|Shaare Zedek Medical Center; Hematology Dept.|
|Jerusalem, Israel, 9103102|
|Hadassah Ein Karem Hospital; Haematology|
|Jerusalem, Israel, 9112001|
|Meir Medical Center; Internal Dept A|
|Kfar Saba, Israel, 44281|
|Western Galilee Hospital - Nahariya|
|Nahariya, Israel, 22100|
|Beilinson Medical Center; Haematology|
|Petach Tikva, Israel, 49100|
|Kaplan Medical Center|
|Rehovot, Israel, 7661041|
|ASSAF Harofe; Department of Hematology|
|Rishon Lezion, Israel, 70300|
|Ichilov Sourasky Medical Center; Heamatology|
|Tel Aviv, Israel, 6423906|
|Study Director:||Clinical Trials||Hoffmann-La Roche|